Novartis Product Recall: 'What Took So Long?' Consumer Blogger Asks

That is what a food safety microbiologist and blogger at eFoodAlert.wordpress.com is asking.

By now, you have heard that on Sunday, Jan. 8, Novartis took the extraordinary measure of voluntarily recalling some of its popular over-the-counter medicines and suspending operations at its Lincoln, Neb., facility.

But this sudden recall has been a long time coming, according to Phyllis Entis, a k a “the food bug lady.” In her post, “Novartis Gives Consumers Excedrin Headache,” she wrote that the Food and Drug Administration uncovered quality problems at the plant last July. She links to the inspection here. She also provides a timeline of earlier, limited recalls.

Novartis in its release Sunday said that the temporary shutdown of its plant was “to accelerate maintenance and other improvement activities at the site.”

Entis, however, wondered: “Is it just possible that FDA’s posting on January 5th of the July 8, 2011 Novartis Inspectional “Observations” Report might be somehow tied into this sudden decision by Novartis to go public?”

For its part, Novartis responded Monday, Jan. 9: “These issues came to light through several quality and regulatory processes that gather consumer feedback on a regular basis as well as internal reviews and FDA inspections. Working with the FDA, we have made commitments to improve these areas and, at the appropriate time, we decided to initiate a market action as a precautionary measure in the best interest of consumers who trust and rely on our products.”

The recall is for some bottles of Excedrin and NoDoz with the expiration dates of Dec. 20, 2014, or earlier. As well, some bottles of Bufferin and Gas-X, with expiration dates of Dec. 20, 2013, or earlier, are included.

In its announcement, Novartis said, “There have been no related adverse events reported with the issues leading to the recall.” Even so, the FDA is asking consumers to report any such adverse effects to its MedWatch Adverse Reporting program.